BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851378 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02192
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    June 18, 2009
    Report Date
    June 19, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE THUMB ADVANCER HAD BEEN UNLOCKED AND RETRACTED PROXIMAL OF THE FINISH WINDOW AFTER CLIP DEPLOYMENT, INDICATING THE ACCESS PORTS WERE USED TO REMOVE THE DEVICE. EXAMINATION OF THE INTERNAL COMPONENTS FOUND THEM IN THE CORRESPONDING POSITIONS OF THE EXTERNAL COMPONENTS AND UNDAMAGED WITH THE EXCEPTION OF THE VESSEL LOCATOR WINGS. DURING CLIP DEPLOYMENT THE VESSEL LOCATORS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT; HOWEVER, THE VESSEL LOCATOR WINGS OF THIS DEVICE WERE BENT DISTALLY. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS DUE TO TISSUE COMPRESSED BETWEEN THE DISTAL END OF THE TUBES AND BEHIND THE OPEN LOCATORS CREATING DISTAL FORCES DURING THUMB ADVANCEMENT BENDING THE LOCATOR WINGS AND SUBSEQUENTLY CONTRIBUTING THE STUCK CONDITION. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE THE ACCESS PORTS WERE USED AND THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 76048-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention